AAMI News January 2020
Chinese Regulatory Authority Meets with AAMI, ANSI
Regulation of Medical Devices in China
The Chinese National Medical Products Administration has two departments that manage medical devices: The Department of Medical Device Registration is responsible for premarket approvals; and the Department of Medical Device Supervision is responsible for postmarket supervision.
Delegates from the Chinese National Medical Products Administration (NMPA) met with AAMI and the American National Standards Institute (ANSI) standards staff in Washington, D.C., as part of a two-week visit organized by the U.S. Trade and Development Agency. The purpose of the gathering was to talk about the U.S. standards system and how standards are used in medical device regulations in the U.S. and internationally.
“The presentations at the bilateral meeting sparked conversation on the differences and similarities in medical device standard development, which helped both countries see how they could better collaborate in the future. The meeting increased knowledge sharing and established a propitious foundation for the continuation of U.S-Chinese collaboration with medical device standardization,” said Henry “Henri” Yuan, ANSI program manager of international development in Washington, D.C.
China recently combined several of its regional regulatory bodies into the NMPA. The national authority is tasked with producing both regulations and standards for governing medical devices. The Chinese NMPA is responsible for the premarket approval and postmarket supervision of medical devices. Its offices include regulatory departments that oversee more than 17,000 manufacturing enterprises and 500,000 medical device enterprises operating in China.
Jordan Strickler, program manager for international policy at ANSI, presented an overview of their standards program. Yuan spoke on the importance of openness and transparency when developing standards, as well as collaboration around conformity assessment efforts between ANSI and the NMPA.
Mu Ruihong, deputy division director of the Medical Devices Standard Division, National Institute for Food and Drug Control, NMPA, gave a talk on standardization management in China that detailed the difference between mandatory and recommended/voluntary standards in their systems, the extent of standards development in the sector, and Chinese efforts in international standardization efforts. She also discussed China’s participation in the International Medical Device Regulators Forum (IMDRF).
AAMI was represented by Joe Lewelling, vice president of emerging technologies and standards, and Emily Hoefer, standards program manager, who explained how international standards developed by the International Organization for Standardization and the International Electrotechnical Commission under the management of AAMI can support regulations and the IMDRF essential principles of safety and performance of medical devices and in vitro diagnostic medical devices.
Other discussion topics included new efforts addressing artificial intelligence (AI), including AI servicing and postmarket safety management, which aligned with the Chinese delegates’ interests.
Patricia Krantz-Zuppen, standards manager, cardiac rhythm and heart failure for Medtronic in Mounds View, MN, joined the AAMI presentation to discuss risk management for medical device software under IEC 62304, Medical device software—Software life cycle processes, of which she is the international project leader.
Following the presentations, attendees discussed the relationship between standards and U.S. Food and Drug Administration regulations, as well as ongoing efforts to harmonize regulations around the IMDRF essential principles.
U.S. standards groups meet with Chinese delegates to discuss medical device standards and regulations.